Thrombolysis for patients gt; 80 ndash; a different view.ppt

Thrombolysis for patients 80 – a different view Peter Sandercock On behalf of the IST3 collaborative Group Some questions Why does age 80 matter? Are people 80 years getting rt-PA? For people aged 80 vs 80 yrs Are the benefits different? Are the risks (intracranial haemorrhage) different? 4. Is there a role for specialist brain imaging to sort out which older patients should receive thrombolysis? 5. Do we need more trials in the over 80s? Why does it matter? It’s a big problem Every year in the UK ~ 30,000 people aged 80 have an acute ischaemic stroke EU approval for thrombolysis excludes 80 year olds Ageism in rt-PA usage Ageism: the older you are, the less likely you are to get rt-PA for stroke: Germany Randomised trial evidence for rt-PA in the over 80’s? 11 randomised trials of rt-PA for stroke 3977 patients Only 42 patients aged 80 years! In patients aged 80: effect on death Non-randomised cohort studies. Outcome after iv thrombolysis for stroke  80 versus 80 years of age: 6 cohort studies included 2,244 patients 477 aged ≥80 years Potential for bias - can’t adjust for baseline differences in those and 80 years Non-randomised cohorts: Death Non- randomised cohorts: good outcome in survivors (mRS 0-1) Summary of non-random studies Imbalances in baseline variables; hard to assess balance of risk and benefit Need reliable randomised evidence on the balance of risk and benefit For stroke patients aged ≥80 years, it is safe and reasonable to include such patients in randomised placebo-controlled trials. Third International Stroke Trial. A large randomised trial to answer the question: can a wider variety of patients be treated with iv therapy? IST-3 trial: randomisation If patient fits main eligibility/exclusion criteria, Clinician/patient/family discuss. If: Clear INDICATION FOR rt-PA ? TREAT (i.e. meets terms of current licence and patient agrees) Clear CONTRAINDICATION TO rt-PA ? DON’T TREAT rt-PA ‘PROMISING BUT UNPROVEN’ ?